System and method for multiple site injection

ABSTRACT

A system for injecting includes a syringe body having proximal and distal ends, a syringe interior, and a syringe flange at the proximal end thereof. The system also includes an injectable fluid disposed in the syringe interior. The system further includes a finger flange coupled to the syringe flange. Moreover, the system includes a stopper member disposed in the syringe interior. In addition, the system includes a plunger ratchet member coupled to the stopper member. The system also includes a plunger tube disposed coaxially around at least a portion of the plunger ratchet member and operatively coupled thereto.

The present application claims priority to (1) U.S. Provisional PatentApplication Ser. No. 62/760,273, filed on Nov. 13, 2018, and entitled“SYSTEM AND METHOD FOR SAFETY SYRINGE.” This application also includessubject matter similar to the subject matter described in the followingco-owned U.S. patent applications: (2) Ser. No. 14/696,342, filed Apr.24, 2015, and entitled “SYSTEM AND METHOD FOR SAFETY SYRINGE”; (3) Ser.No. 14/543,787, filed Nov. 17, 2014, and entitled “SYSTEM AND METHOD FORDRUG DELIVERY WITH A SAFETY SYRINGE”; (4) Ser. No. 14/321,706, filedJul. 1, 2014, and entitled “SAFETY SYRINGE”; and (5) Ser. No.62/416,102, filed Nov. 1, 2016, and entitled “SYSTEM AND METHOD FORSAFETY SYRINGE”; (6) Ser. No. 62/431,382, filed Dec. 7, 2016, andentitled “SYSTEM AND METHOD FOR SAFETY SYRINGE”; (7) Ser. No.62/480,276, filed Mar. 31, 2017, and entitled “SYSTEM AND METHOD FORSAFETY SYRINGE; (8) Ser. No. 62/508,508, filed May 19, 2017, andentitled “SYSTEM AND METHOD FOR COLLECTING INJECTION INFORMATION”; (9)Ser. No. 62/542,230, filed Aug. 7, 2017, (10) Ser. No. 15/801,239, filedNov. 1, 2017, and entitled “SYSTEM AND METHOD FOR SAFETY SYRINGE”; (11)Ser. No. 15/801,259, filed Nov. 1, 2017, and entitled “SYSTEM AND METHODFOR SAFETY SYRINGE”; (12) Ser. No. 15/801,281, filed Nov. 1, 2017, andentitled “CARTRIDGE SAFETY INJECTION SYSTEM AND METHODS”; (13) Ser. No.15/801,304, filed Nov. 1, 2017, and entitled “SYSTEM AND METHOD FORSAFETY SYRINGE”; (14) Ser. No. 16/011,453, filed Jun. 18, 2018, andentitled “SYSTEM AND METHOD FOR SAFETY SYRINGE”; (15) Ser. No.15/985,354, filed May 21, 2018, and entitled “SYSTEM AND METHOD FORCOLLECTING INJECTION INFORMATION”; and “(16) Ser. No. 16/683,126, filedNov. 13, 2019, and entitled “SYSTEM AND METHOD FOR MICRODOSE INJECTION”.The contents of the above-mentioned applications are fully incorporatedherein by reference as though set forth in full.

FIELD OF THE INVENTION

The present invention relates generally to injection systems, devices,and processes for facilitating various levels of control over fluidinfusion, and more particularly to systems and methods related tosyringes for delivery microliter range doses of fluids in healthcareenvironments.

BACKGROUND

Millions of syringes, such as that depicted in FIG. 1A 2, are consumedin healthcare environments every day. A typical syringe 2 includes atubular body 4, a plunger 6, and an injection needle 8. As shown in FIG.1B, such a syringe 2 may be utilized not only to inject fluid into apatient, but also to withdraw or expel fluid out of or into a containersuch as a medicine bottle, vial, bag, or other drug containment system10. Indeed, due to regulatory constraints in some countries such as theUnited States as well as sterility maintenance concerns, upon use of amedicine bottle 10 with a syringe 2 as shown in a particular patient'senvironment, such medicine bottle may only be utilized with a singlepatient and then must be disposed of—causing significant medical wastefrom bottle and remaining medicine disposal, and even contributing toperiodic shortages of certain critical drugs.

Referring to FIG. 2A, three Luer-type syringes 12 are depicted, eachhaving a Luer fitting geometry 14 disposed distally, so that they may becoupled with other devices having similar mating geometry, such as theLuer manifold assembly 16 depicted in FIG. 2B. The Luer manifoldassembly of FIG. 2B may be used to administer liquid drugs to thepatient intravenously with or without the use of an intravenous infusionbag. The Luer fittings 14 of the syringes of FIG. 2A may be termed the“male” Luer fittings, while those of FIG. 2B 18 may be termed the“female” Luer fittings; one of the Luer interfaces may be threaded (inwhich case the configuration may be referred to as a “Luer lock”configuration) so that the two sides may be coupled by relativerotation, which may be combined with compressive loading. In otherwords, in one Luer lock embodiment, rotation, possibly along withcompression, may be utilized to engage threads within the male fitting14 which are configured to engage a flange on the female fitting 18 andbring the devices together into a fluid-sealed coupling. In anotherembodiment, tapered interfacing geometries may be utilized to providefor a Luer engagement using compression without threads or rotation(such a configuration may be referred to as a “slip-on” or “conical”Luer configuration). While such Luer couplings are perceived to berelatively safe for operators, there is risk of medicinespilling/leaking and parts breakage during the loading to provide a Luercoupling. The use of needle injection configurations, on the other hand,carries with it the risk of a sharp needle contacting or poking a personor structure that is not desired. For this reason, so called “safetysyringes” have been developed.

One embodiment of a safety syringe 20 is shown in FIG. 3 , wherein atubular shield member 22 is spring biased to cover the needle 8 whenreleased from a locked position relative to the syringe body 4. Anotherembodiment of a safety syringe 24 is shown in FIGS. 4A-4B. With such aconfiguration, after full insertion of the plunger 6 relative to thesyringe body 4, the retractable needle 26 is configured to retract 28,26 back to a safe position within the tubular body 4, as shown in FIG.4B. Such a configuration which is configured to collapse upon itself maybe associated with blood spatter/aerosolization problems, the safestorage of pre-loaded energy which may possible malfunction and activatebefore desirable, loss of accuracy in giving full-dose injections due toresidual dead space within the spring compression volume, and/or loss ofretraction velocity control which may be associated with pain andpatient anxiety.

Further complicating the syringe marketplace is an increasing demand forpre-filled syringe assemblies such as those depicted in FIGS. 5A and 5B,which generally include a syringe body, or “drug enclosure containmentdelivery system”, 34, a plunger tip, plug, or stopper 36, and a distalseal or cap 35 which may be fitted over a Luer type interface (FIG. 5Ashows the cap 35 in place; FIG. 5B has the cap removed to illustrate theLuer interface 14. Liquid medicine may reside in the volume, or medicinereservoir, 40 between the distal seal 35 and the distal end 37 of thestopper member 36. The stopper member 36 may include a standard butylrubber material and may be coated, such as with a biocompatiblelubricious coating (e.g., polytetrafluoroethylene (“PTFE”)), tofacilitate preferred sealing and relative motion characteristics againstthe associated syringe body 34 structure and material. The proximal endof the syringe body 34 in FIG. 5B includes a conventional integralsyringe flange 38), which is formed integral to the material of thesyringe body 34. The flange 38 is configured to extend radially from thesyringe body 34 and may be configured to be a full circumference, or apartial circumference around the syringe body 34. A partial flange isknown as a “clipped flange” while the other is known as a “full flange.”The flange is used to grasp the syringe with the fingers to providesupport for pushing on the plunger to give the injection. The syringebody 34 preferably includes a translucent material such as a glass orpolymer. To form a contained volume within the medicine chamber orreservoir 40, and to assist with expulsion of the associated fluidthrough the needle, a stopper member 36 may be positioned within thesyringe body 34. The syringe body may define a substantially cylindricalshape (i.e., so that a plunger tip 36 having a circular cross sectionalshape may establish a seal against the syringe body), or be configuredto have other cross sectional shapes, such as an ellipse.

Such assemblies are desirable because they may be standardized andproduced with precision in volume by the few manufacturers in the worldwho can afford to meet all of the continually changing regulations ofthe world for filling, packaging, and medicine/drug interfacingmaterials selection and component use. Such simple configurations,however, generally will not meet the new world standards for single-use,safety, auto-disabling, and anti-needle-stick. Thus certain suppliershave moved to more “vertical” solutions, such as that 41 featured inFIG. 5C, which attempts to meet all of the standards, or at least aportion thereof, with one solution; as a result of trying to meet thesestandards for many different scenarios, such products may havesignificant limitations (including some of those described above inreference to FIGS. 3-4B) and relatively high inventory and utilizationexpenses.

Some medications are delivered to multiple sites in a patient during asingle treatment. At the same time, after a treatment, a needle mayremain exposed, increasing the probability of inadvertent needle sticks.

There is a need for injection systems which address shortcomings ofcurrently-available configurations. In particular, there is a need forinjection systems that inject fluids in multiple sites in one patient.Further, there is a need for safe injection systems that function withsuch multi-site injection systems. It is also desirable that suchsyringe assemblies may utilize the existing and relativelywell-controlled supply chain of conventionally delivered pre-filledcartridges and other off-the-shelf components, and the correspondingassembly machinery and personnel.

SUMMARY

Embodiments are directed to injection systems. In particular, theembodiments are directed to microliter range injection systems thatinclude at least some off-the-shelf syringe components.

In one embodiment, a system for injecting includes a syringe body havingproximal and distal ends, a syringe interior, and a syringe flange atthe proximal end thereof. The system also includes an injectable fluiddisposed in the syringe interior. The system further includes a fingerflange coupled to the syringe flange. Moreover, the system includes astopper member disposed in the syringe interior. In addition, the systemincludes a plunger ratchet member coupled to the stopper member. Thesystem also includes a plunger tube disposed coaxially around at least aportion of the plunger ratchet member and operatively coupled thereto.

In one or more embodiments, the system also includes a needle hubassembly coupled to the syringe body at the distal end, the needleassembly including: a non-retractable needle and a luer hub. The needlemay be selected from the group consisting of 30 g needles, 32 g needles,34 g needles, and sub 34 g needles.

In one or more embodiments, the plunger ratchet member includes needleretention feature disposed in a plunger interior, an energy-storagemember disposed in the plunger interior, and an energy-storage memberlatching member disposed in the plunger interior. The system may alsoinclude a needle hub assembly coupled to the syringe body at its distalend. The needle assembly may include a needle having a needle proximalend feature, a hub, and a needle latching member configured toselectively prevent the needle from moving proximally relative to thehub. The needle may be at least partially retractable into the plungerinterior upon manipulation of the plunger tube to transform theenergy-storage member latching member from a latched state to anunlatched state. The needle may be configured to pierce entirely throughthe stopper member to be at least partially retracted into the plungerinterior. The energy-storage member may be intercoupled between aninterior surface of the plunger ratchet member and the needle retentionfeature. The plunger ratchet member may include a plurality of teethdisposed on an outside surface thereof. A distal end of the plunger tubemay include a reduced diameter portion configured to interfere with eachtooth of the plurality to prevent distal movement of the plunger tuberelative to the plunger ratchet member. The energy-storage memberlatching member may be configured to transform from a latched state toan unlatched state after the reduced diameter portion of the plungertube moves proximally past a proximal-most tooth of the plurality. Theneedle may be selected from the group consisting of 30 g needles, 32 gneedles, 34 g needles, and sub 34 g needles.

In one or more embodiments, the system also includes a thumbpad coupledto a proximal end of the plunger tube. The plunger ratchet member mayinclude a plurality of teeth disposed on an outside surface thereof. Adistal end of the plunger tube may include a reduced diameter portionconfigured to interfere with each tooth of the plurality to preventdistal movement of the plunger tube relative to the plunger ratchetmember.

In one or more embodiments, the system also includes a ratchet retentionmember having a latch configured to interfere with the plurality ofteeth on the plunger ratchet member to limit proximal movement of theplunger ratchet member relative to the ratchet retention member. Theratchet retention member may include a pair of elastic latches disposedon opposite sides thereof. The ratchet retention member may be formedfrom a sheet of metal. The finger flange may define a space sized andshaped to hold the ratchet retention member. The finger flange may alsodefine a side opening leading into the space. The pitch of the teeth maybe sized to provide a consistent injection dose per tooth. The pluralityof teeth may consist of 10 teeth. The reduced diameter portion mayinclude a plurality of leaves directed toward a longitudinal axis of theplunger tube. The plurality of leaves may consist of four leaves.

In one or more embodiments, moving the plunger tube from its proximalposition to its distal position ejects a fixed volume of the fluid fromthe syringe interior. The finger flange may include a distal stoppingsurface configured to limit distal movement of the plunger tube beyondits distal position, thereby prevents ejection of more than the fixedvolume of fluid from the syringe interior. The fixed volume may beapproximately 0.1 ml. The stopper member may be an off the shelf stoppermember. The syringe body may be an off the shelf syringe body. Theplunger ratchet member may define a drive recess at a proximal endthereof.

In one or more embodiments, the finger flange includes a proximallyextending tube disposed coaxially around a portion of the plunger tube,and a return spring configured to bias the plunger tube from a distalposition to a proximal position. The plunger tube may include a proximalflange configured to limit distal movement of the plunger tube relativeto the proximally extending tube of the finger flange. The plunger tubemay include a plurality of tabs directed away from a longitudinal axisof the plunger tube. The proximally extending tube of the finger flangemay define a corresponding plurality of windows configured to interferewith the plurality of tabs to limit proximal movement of the plungertube relative to the proximally extending tube of the finger flange. Theplunger tube may be disposed coaxially within the syringe body. Thesystem may also include a priming screw configured to advance theplunger ratchet member to remove air from the syringe interior and ejecta portion of the injectable fluid from the syringe interior.

In one or more embodiments, the finger flange includes a lever, theplunger ratchet member is operatively coupled to the lever, and theplunger tube is operatively coupled to the lever. The plunger tube maybe disposed coaxially within the syringe body. The finger flange mayalso include a link coupling the plunger tube to the lever. The fingerflange may also include a spring operatively coupled to the lever. Thelever may have a proximal position and a distal position. The spring maybias the lever in the proximal position.

In one or more embodiments, the plunger tube has a proximal positioncorresponding to the proximal position of the lever and a distalposition corresponding to the distal position of the lever. The springmay bias the plunger tube in the proximal position. Moving the plungertube from its proximal position to its distal position may move thelever from its proximal position to its distal position and may move theplunger ratchet member distally relative to the finger flange. Thefinger flange may include a distal stopping surface configured to limitdistal movement of the plunger tube beyond its distal position, therebyprevents ejection of more than the fixed volume of fluid from thesyringe interior.

In one or more embodiments, moving the plunger tube from its proximalposition to its distal position by a first distance moves the plungerratchet member distally relative to the finger flange by a seconddistance, thereby dispensing the injectable fluid from the syringe body.A ratio of the first distance to the second distance may be in the rangeof 1 to 5. The ratio of the first distance to the second distance may beapproximately 2.5.

In one or more embodiments, applying a first force to the plunger tubeapplies a second force to the plunger ratchet member, wherein a ratio ofthe second force to the first force is a force ratio. The force ratiomay be in the range of 1 to 5. The force ratio may be approximately 2.5.The force ratio may reduce the amount of force applied to the plungertube to inject viscous medicine through a needle. The plunger tube andthe plunger ratchet member may define a space at a proximal end of theplunger tube when the plunger tube is in its proximal position.

In one or more embodiments, the plunger ratchet member has a smoothexterior surface, and the plunger tube includes a pair of inwardlybiased members configured to allow distal movement of the plungerratchet member relative to the plunger tube, while preventing proximalmovement of the plunger ratchet member relative to the plunger tube. Thepair of inwardly biased members may be configured to deform a surface ofthe plunger ratchet member.

In another embodiment, a method for assembling a system for injectingincludes mounting a finger flange to a pre-filled syringe. Thepre-filled syringe includes a syringe body defining a syringe interior,an injectable fluid disposed in the syringe interior, and a stoppermember disposed in the syringe interior and retaining the injectablefluid in the syringe interior. The finger flange includes a plunger tubehave a proximal opening therein. The method also includes inserting aplunger ratchet member through the proximal opening into the plungertube. The method further includes coupling the plunger ratchet member tothe stopper member in the syringe interior.

In one or more embodiments, the method also includes capping theproximal opening in the plunger tube with a thumb pad. The plungerratchet member may include a plurality of teeth disposed on an outsidesurface thereof. A distal end of the plunger tube may include a reduceddiameter portion configured to interfere with each tooth of theplurality to prevent distal movement of the plunger tube relative to theplunger ratchet member. The method may also include inserting a plungerratchet member through the proximal opening into the plunger tube untila distal most tooth of the plurality of teeth moves distally past thereduced diameter portion to thereby limit proximal movement of theplunger ratchet member relative to the plunger tube and finger flange.

In one or more embodiments, the finger flange includes a proximallyextending tube disposed coaxially, and a return spring configured tobias the plunger tube from a distal position to a proximal position. Themethod may also include inserting the plunger tube into the proximallyextending tube thereby compressing the return spring. The finger flangemay include a lever, and a link operatively coupled to the lever. Themethod may also include inserting the plunger tube into the fingerflange thereby operatively coupling the plunger tube to the lever viathe link.

In still another embodiment, a system for injecting includes a syringebody having proximal and distal ends, a syringe interior, and a syringeflange at the proximal end thereof. The system also includes a fingerflange coupled to the syringe flange, the finger flange including aplunger return spring. The system further includes a stopper memberdisposed in the syringe interior. Moreover, the system includes aplunger member coupled to the stopper member and operatively coupled tothe plunger spring. The plunger member has a proximal position and adistal position. The plunger spring biases the plunger member in theproximal position.

In one or more embodiments, when the plunger member is in the proximalposition, the stopper member and the syringe body define a distalchamber. The plunger member may have a proximal chamber. The stoppermember and a distal end of the plunger member may form a proximalone-way valve configured to fluidly couple the proximal and distalchambers when the plunger member is in the proximal position, and tofluidly isolate the proximal chamber from the distal chamber when theplunger member is in the distal position. The system may also include adistal one-way valve configured to fluidly couple the distal chamber andan opening at the distal end of the syringe body when the plunger memberis in the distal position, and to fluidly isolate the distal chamberfrom the opening when the plunger member is in the proximal position.The stopper member may define a space. The distal end of the plungermember may be movably disposed in the space to movably couple theplunger member to the stopper member. The distal one-way valve mayinclude a spherical member and a valve spring biasing the sphericalmember in a proximal position to close the distal one-way valve. Movingthe plunger member from the distal position to the proximal position mayclose the distal one-way valve and opens the proximal one-way valve toallow a fluid in the proximal chamber to flow into the distal chamber.

In one or more embodiments, moving the plunger member from the proximalposition to the distal position closes the proximal one-way valve andopens the distal one-way valve to allow a fluid in the distal chamber toflow out of the distal opening of the syringe body. Moving the plungermember from the proximal position to the distal position may eject afixed volume of fluid from the distal chamber out of the distal openingof the syringe body. The fixed volume may be approximately 0.1 ml. Theneedle may be selected from the group consisting of 30 g needles, 32 gneedles, 34 g needles, and sub 34 g needles. The system may also includea thumbpad coupled to a proximal end of the plunger member. The syringebody may be an off the shelf syringe body.

The aforementioned and other embodiments of the invention are describedin the Detailed Description which follows.

BRIEF DESCRIPTION OF THE DRAWINGS

The foregoing and other aspects of embodiments are described in furtherdetail with reference to the accompanying drawings, in which the sameelements in different figures are referred to by common referencenumerals, wherein:

FIGS. 1A-5C illustrate various aspects of conventional injection syringeconfigurations.

FIGS. 6-15C illustrate various aspects of a multiple site injectionsystem and a multiple site injection method according to someembodiments.

FIGS. 16-28 illustrate various aspects of a multiple site injectionsystem and a multiple site injection method according to someembodiments.

FIGS. 29-36 illustrate various aspects of a multiple site injectionsystem and a multiple site injection method according to someembodiments.

FIGS. 37-42B illustrate various aspects of a multiple site injectionsystem and a multiple site injection method according to someembodiments.

FIGS. 43-47C illustrate various aspects of a multiple site injectionsystem and a multiple site injection method according to someembodiments.

FIGS. 48-54 illustrate various aspects of a multiple site injectionsystem and a multiple site injection method according to someembodiments.

FIGS. 55-67 illustrate various aspects of a multiple site injectionsystem and a multiple site injection method according to someembodiments.

FIGS. 68-74 illustrate various aspects of a multiple site injectionsystem and a multiple site injection method according to someembodiments.

In order to better appreciate how to obtain the above-recited and otheradvantages and objects of various embodiments, a more detaileddescription of embodiments is provided with reference to theaccompanying drawings. It should be noted that the drawings are notdrawn to scale and that elements of similar structures or functions arerepresented by like reference numerals throughout. It will be understoodthat these drawings depict only certain illustrated embodiments and arenot therefore to be considered limiting of scope of embodiments.

DETAILED DESCRIPTION OF ILLUSTRATED EMBODIMENTS Exemplary Multiple SiteInjection Systems

Many injectable medications can be administered to multiple injectionsites on the same patient. Some medical procedures involve injection offixed volumes (e.g., 0.1 ml and/or microdose volumes) of medications(e.g., botulinum toxin or “Botox”) at multiple injection sites on apatient. Currently, many medicines are drawn into an injection systemfrom a vial, which increases procedure time and exposure of a needle forunintended punctures. Further, some medications are delivered in aviscous solution, and therefore require a larger diameter (e.g., lowergauge: 25 g) needle to be used to draw the viscous medication into theinjection system and a smaller diameter (e.g., higher gauge: 30 g, 32 g,34 g, sub-34 g) needle to be use for the injection. This exchange ofneedles results in increased procedure time and risk of unintendedpunctures. The multiple site injection system described herein addressesthese issues of current systems.

FIGS. 6-15C depict a multiple site injection system 500 according tosome embodiments. As shown in FIG. 6 , the system 500 can be prefilledwith an injectable medication. The system 500 includes a syringe body510, a needle assembly 590, a stopper member 520, a plunger member 550,and a finger flange 540. Many of these system components (e.g., thesyringe body 510, the stopper member 520, and needle member 590) may beoff-the-shelf components to utilize the existing and relativelywell-controlled supply chain, and the corresponding assembly machineryand personnel. The syringe body 510 may be glass, metal, or polymericmaterials such as COC, COP, polypropylene, polyethylene, or othersyringe material. The stopper member 520 may be rubber such as butyl,chlorobutyl, bromobutyl, or a polymeric material such as a thermoplasticelastomer. The stopper member 520 may be covered in a protective and/orlubricious coating such as PTFE or other polymer. The stopper member 520being off-the-shelf refers to a commercially available stopper member,which has a generally smooth distally facing surface which contains noprojections or recesses for coupling to a needle. The system 500 alsoincludes a plunger tube 560 configured to apply distally directed forceto the plunger member 550 and the stopper member 520 coupled thereto.

FIG. 7 is an exploded view, FIGS. 8 and 9 are detailed perspectiveviews, FIGS. 10 and 11 are detailed partial longitudinal cross-sectionviews, all showing various internal components of the multiple siteinjection system 500 according to some embodiments. The finger flange540 includes a ratchet pawl 542, a lever arm 544, a link 546, and areturn spring 548, which are all contained in a flange housing 549. Theplunger tube 560 includes an arm 562 and a thumb pad 564. The plungermember 550 includes a ratchet surface 552 having a plurality of teeth554.

When assembled as shown in FIGS. 8-11 , the thumb pad 564 is operativelycoupled to the ratchet pawl 542 through the plunger tube 560, the arm562, the link 546, and the lever arm 544. As such, when distallydirected force is applied to the thumb pad 564, the lever arm 544increases and transmits the distally directed force to the ratchet pawl542. Depending on the relative dimensions of the lever arm 544, theratio of the distances traveled by the plunger tube 560 and the plungermember 550 may be anywhere from about one to about five. In oneembodiment, the distance ratio is approximately 2.5:1. Similarly, theforce ratio of the force applied to the thumb pad 564 and the forceexerted on the ratchet pawl 542 may be anywhere from about one to aboutfive. In one embodiment, the force ratio is approximately 2.5:1.

The return spring 548 biases the lever in the proximal direction.Accordingly, after a user presses the thumb pad 564 to move the plungertube 560 distally, releasing the pressure on the thumb pad 564 allowsthe thumb pad 564 and the plunger two 562 return to a proximal position.As shown in FIGS. 10 and 11, the ratchet pawl 542 includes a reduceddiameter section 543 at a distal end thereof. This reduced diametersection 543 interferes with the teeth 554 on the ratchet surface 552 ofthe plunger member 550, which allows the ratchet pawl 542 to moveproximally, but not distally, relative to the plunger member 550. In thedistal direction, the ratchet pawl 542 can apply the force to theplunger member 550. As shown in FIG. 9 , the ratchet pawl 542 furtherincludes a plurality of slots 561 configured to allow the reduceddiameter section 543 to expand radially upon return of the plunger tube560 to allow the ratchet pawl 542 to engage the next adjacent plungermember 550 ratchet tooth 554. When the return spring 548 moves theratchet pawl 542 proximally, the reduced diameter section 543 and theslots 561 are configured to allow the ratchet pawl 542 to moveproximally over the plunger member 550. The lever arm 544 is configuredsuch that moving the ratchet pawl 542 from a distal position to aproximal position moves the reduced diameter section 543 thereof fromone tooth 554 to the next tooth 554 in a proximal direction. This movesthe plunger member 550 distally by a distance of one tooth 554. Thevarious components of the system 500 can be configured such that movingthe plunger member 550 distally by a distance of one tooth 554 ejects apredetermined volume (e.g., 0.1 ml, microdose) of fluid from an interiorof the syringe body 510. The spacing between ribs/teeth 554 may beconstant along the length of the plunger member 550 to deliver constantdoses per injection or may be variable along the length of the plungermember 550 to deliver different doses per injection. Consequently, auser can serially advance the plunger member 550 in the syringe body 510and eject a predetermined volume of fluid by alternately depressing andreleasing the thumb pad 564.

FIGS. 12-14 depict assembly of a multiple site injection system 500according to some embodiments. In FIGS. 12 , plunger tube 560 has beeninserted coaxially around the ratchet pawl 542 and into the fingerflange 500 until the arm 562 on the plunger tube 560 engages and thelink 546 attached to the lever arm 544. The finger flange 540 is snappedonto a prefilled and pre-stoppered syringe 510. The plunger rod 550 isthen inserted into the finger flange 540 through the plunger tube 560and coupled (e.g., screwed or pressed into) to the stopper member 520.The thumbpad 564 may then be snapped onto the plunger tube 560 tocomplete the assembly. The system 500 depicted in FIGS. 12-14 include apre-attached staked needle 592. The needle 592 is provided to the enduser covered in a needle shield 595. The needle shield 595 may beconstructed of a rubber internal needle contacting component and aplastic outer covering. Alternate needles may be of the user attachedluer type, or pre-attached retractable safety needles.

In FIG. 13 , a lateral opening in the finger flange 540 is slid over theglass flange of the syringe body 510 to removably couple the fingerflange 540 to the syringe body 510. The plunger member 550 is insertedthrough the finger flange 540, the plunger tube 560, and the ratchetpawl 542 until the reduced diameter section 543 of the ratchet pawl 542engages the distal most tooth 554 on the plunger member 550. Thisengagement can be determined either by a distance, audio, and/or tactileindicator that the reduced diameter section 543 has moved over a distalmost tooth 554 of the longer member 550.

In FIG. 14 , the thumb pad 564 is coupled to a proximal end of theplunger tube 560 to complete the assembly. After the thumb pad 564 iscoupled to the plunger tube 560, the multiple site injection system 500is ready for use. The needle shield 595 has been removed to administerthe injection

FIGS. 15A-15C depict an injection of a first dose of a plurality ofdoses (e.g., microdoses) using the multiple site injection system 500depicted in FIGS. 6-14 . In FIG. 15A, the multiple site injection system500 has been assembled and is ready for use. The return spring 548 isbiasing the lever arm 542 in a proximal position. The plunger member 550has been inserted until a distal most tooth 554A has moved distally pastand is engaging the reduced diameter section 543 of the ratchet pawl542.

FIG. 15B shows the result of a user applying a distally directed forceto the thumb pad 564. The distally directed force is transmitted throughthe arm 562 at the distal end of the plunger tube 562 to the link 546and onto the lever arm 544, which moves from its proximal position (seeFIG. 15A) to its distal position (see FIG. 15B). As the lever arm 544moves from its proximal to its distal position, the ratchet pawl 542moves distally relative to the finger flange 540 and the syringe body510 coupled thereto. An interference between the reduced diametersection 543 of the ratchet pawl 542 and the distal most tooth 554Acauses the plunger member 550 to move distally along with the ratchetpawl 542. Because the ratchet pawl 542 and the plunger member 550 movedistally a shorter distance than the plunger tube 560, there is a space566 at the proximal end of the plunger tube 560 to accommodate theproximal end of the plunger member 550 can move as the plunger tube 560moves distally over the plunger member 550. As the plunger member 550 tomove distally relative to the syringe body 510, the stopper member 520coupled thereto also moves distally relative to the syringe body 510,thereby ejecting a fixed dose volume of fluid from the syringe body 510and out through the needle assembly 590.

FIG. 15C shows the result of the user releasing the distally directedforce from the thumb pad 564. The return spring 548 moves the lever arm544 from its distal position (see FIG. 15B) to its proximal position(see FIG. 15C). As the lever arm 544 moves proximally, it moves both theratchet pawl 542 and the plunger tube 560 proximally. As the ratchetpawl 542 moves proximally, the elastic nature of the reduced diametersection 543 thereof allows it to expand and slide proximally over theslanted penultimate distal tooth 554B. The system 500 is configured suchthat each depression of the thumb pad 564 and plunger tube 560 moves theplunger member 550 distally by the distance of one tooth 554.Accordingly, after the lever arm 544 has returned to its proximalposition, the reduced diameter section 543 of the ratchet pawl 542 isnow engaged with the next tooth 554 in the distal direction (i.e., 554B)on the plunger member 550.

As such, the multiple site injection system 500 shown in FIG. 15C isready for another injection. The injection process shown in FIGS.15A-15C can be repeated to give a series of injections having a fixedvolume (e.g., 0.1 ml, microdose) until the plunger member 550 has moveddistally until the proximal most tooth 554 has move distally past and isno longer engaged with the reduced diameter section 543 of the ratchetpawl 542. Although not shown in the figures, after the multiple siteinjection system 500 has delivered its last injection, the needle 592 inthe needle assembly 590 may be retracted proximally completely throughthe stopper member 520 and at least partially into the plunger member550 so that the sharp end of the needle 592 is no longer exposed tominimize unintended needle punctures. Such needle retraction systems areshown in co-owned U.S. patent application Ser. Nos. 14/696,342,14/543,787, 14/321,706, 62/416,102, 62/431,382, 62/480,276, 62/508,508,62/542,230, 15/801,239, 15/801,259, 15/801,281, 15/801,304, the contentsof which were previously fully incorporated herein by reference asthough set forth in full.

FIGS. 16-28 depict a multiple site injection system 700 according tosome embodiments. As shown in FIGS. 16-17 and 25-27 , the system 700includes a syringe body 710, a needle assembly 790, a needle cover 730,a stopper member 720, a plunger member 750, a finger flange 740, and aproximal tube 742. Many of these system components (e.g., the syringebody 710, the stopper member 720, and the needle cover 730) may beoff-the-shelf components to utilize the existing and relativelywell-controlled supply chain, and the corresponding assembly machineryand personnel. The syringe body 710 may be glass, metal, or polymericmaterials such as COC, COP, polypropylene, polyethylene, or othersyringe material. The stopper member 720 may be rubber such as butyl,chlorobutyl, bromobutyl, or a polymeric material such as a thermoplasticelastomer. The stopper may be covered in a protective and/or lubriciouscoating such as PTFE or other polymer. The stopper member 720 beingoff-the-shelf refers to a commercially available stopper member, whichhas a generally smooth distally facing surface that contains noprojections or recesses for coupling to a needle. The proximal tube 742includes a thumb pad 744, coupled to a proximal end thereof tofacilitate user application of a distally directed force to the proximaltube 742, the plunger member 750, and the stopper member 720 coupledthereto. As explained below, the system 700 may also include aninjectable fluid (e.g., medications) disposed in a the syringe body 710.

As shown in FIG. 17-20C, the finger flange 740 includes a ratchetingmechanism including the proximal tube 742, which extends proximallytherefrom. The ratcheting mechanism also includes a ratchet tube 760coaxially displaced inside of the proximal tube 742 and the plungermember 750. The plunger member 750 includes a plurality of sawtoothribs/teeth 752 disposed serially along the longitudinal axis thereof(see FIGS. 20A-20C). The ratchet tube 760 includes a plurality (e.g.,four) of the elastically deformable leaves 762 operatively coupled tothe sawtooth ribs 752 on the plunger member 750. In an alternativeembodiment, the ratchet tube 760 may include a single elasticallydeformable leaf 762. The ratcheting mechanism further includes a returnspring 748, which biases the ratchet tube 760 in a proximal position inwhich a flange 766 on a proximal end of the ratchet tube 760 is spacedapart from a proximal end of the proximal tube 742 (see FIG. 17 ).

The leaves 762 interferes with the ribs/teeth 752 on the plunger member750, which allows the ratchet tube 760 to move proximally, but notdistally, relative to the plunger member 750. In the distal direction,the ratchet tube 760 can apply the force to the plunger member 750. Whenthe return spring 748 moves the ratchet tube 760 proximally, the leaves762 flex radially inward to allow the ratchet tube 760 to moveproximally over the plunger member 750. The system 700 is configuredsuch that moving the ratchet tube 760 from a distal position to aproximal position moves the leaves 762 thereof from one rib/tooth 752 tothe next rib/tooth 752 in a proximal direction. This moves the plungermember 750 distally by a distance of one rib/tooth 752. The variouscomponents of the system 500 can be configured such that moving theplunger member 750 distally by a distance of one rib/tooth 752 ejects apredetermined volume (e.g., 0.1 ml, microdose) of fluid from an interiorof the syringe body 710. Consequently, a user can serially advance theplunger member 750 in the syringe body 710 and eject a predeterminedvolume of fluid by alternately depressing and releasing the thumb pad744.

FIG. 18 depicts a finger flange 740 for use with the multiple siteinjection system 700. The proximal tube 742 aligns the ratchet tube 760and the plunger member 750 of the ratcheting mechanism. The proximaltube 742 also has a proximal end 741, which provides a hard stop againstthe flange 766 on the proximal end of the ratchet tube 760. The distancebetween the proximal end of the proximal tube 742 and the flange 766 onthe proximal end of the ratchet tube 760 defines the travel of theplunger member 750 per injection. The proximal tube 742 also includes aplurality (e.g., two) of windows 746 configured to interfere withanti-pullout tabs 768 on the ratchet tube 760.

FIG. 19 depicts a ratchet tube 760 for use with the multiple siteinjection system 700. The ratchet tube 760 includes a plurality (e.g.,four) of elastic leaves 762 configured to interfere with the ribs/teeth752 on the plunger member 750. In an alternative embodiment, the ratchettube 760 may include a single elastically deformable leaf 762. Theratchet tube 760 also includes a plurality (e.g., two) of anti-pullouttabs 768 configured to extend to interfere with the windows 746 and theproximal tube 742. In an alternative embodiment the ratchet tube 760 mayinclude a single anti-pullout tab 768. The ratchet tube 760 furtherincludes a flange 766 configured to interfere with the proximal end ofthe proximal tube 742 to define a single injection stroke.

FIGS. 20A-20C depicts a plunger member 750 for use with the multiplesite injection system 700. The plunger member 750 includes a pattern ofserial sawtooth ribs/teeth 752 on external surfaces thereof. The spacingbetween the ribs/teeth 752 can be modified to adjust the dosagedelivered by the multiple site injection system 700. The spacing betweenribs/teeth 752 may be constant along the length of the plunger member750 to deliver constant doses per injection or may be variable along thelength of the plunger member 750 to deliver different doses perinjection. The plunger member 750 also includes a needle retractionmechanism similar to the ones depicted and described in co-owned U.S.patent application Ser. Nos. 14/696,342, 14/543,787, 14/321,706,62/416,102, 62/431,382, 62/480,276, 62/508,508, 62/542,230, 15/801,239,15/801,259, 15/801,281, 15/801,304, the contents of which werepreviously fully incorporated herein by reference as though set forth infull.

FIGS. 21 and 22 depict the proximal and distal positions of the ratchettube 760 relative to the proximal tube 742 of the finger flange 740. Inthe proximal position depicted in FIG. 21 , the return spring 748 pushesthe ratchet tube 760 proximally until the anti-pullout tabs 768 on theratchet tube 760 interfere with the windows 746 in the proximal tube742. In the distal position depicted in FIG. 22 , a user applies adistally directed force to the thumb pad 744 pushing the ratchet tube760 distally until the flange 766 on the ratchet tube 760 interfereswith the proximal end of the proximal tube 742. This mechanism definesthe stroke length of the dose injection, thereby reducing overdosesituations.

FIGS. 23A-C and 24A-C depict a single injection cycle using the multiplesite injection system 700. In FIGS. 23A and 24A, the system 700 is readyfor its first injection with the leaves 762 on the ratchet tube 760engaged in the first sawtooth ribs/teeth 752 on the plunger member 750.As the user depresses the thumb pad 744, the leaves 762 transmits thedistally directed force to the ribs/teeth 752, thereby advancing theplunger member 750 and the stopper member 720 coupled thereto by thedistance of approximately one rib/tooth 752. Advancement of the stoppermember 720 ejects a fixed volume (e.g., 0.1 ml, microdose) of fluid froman interior of the syringe body 710.

In FIGS. 23B and 24B, the user has depressed the thumb pad 744 asdescribed above. Advancing the ratchet tube 760 also compresses thereturn spring 748. The interference between the flange 766 on theratchet tube 760 and the proximal end of the proximal tube 742 definesto stroke length and reduces overdose situations. The ratchet tube 760also includes a space 764 at a proximal end thereof to accommodate theproximal end of the plunger member 750 at the bottom of the firststroke.

In FIGS. 23C and 24C, the user has released the thumb pad 744. Thereturn spring 748 expands and moves the ratchet tube 760 proximally overthe plunger member 750 which is held in place by friction between thestopper member 720 and the syringe body 710. As the tube 760 movesproximally, the elastically deformable leaves 762 glide over thesawtooth geometry of the ribs/teeth 752 and moves from the firstrib/tooth 752 to the next proximal rib/tooth 752. Accordingly, theratchet tube 760 and the thumb pad 744 returned to a ready position forthe next injection while the plunger member 750 remains in positionhaving advanced by a distance of one rib/tooth 752.

The injection process shown in FIGS. 23A-24C can be repeated to give aseries of injections having a fixed volume (e.g., 0.1 ml, microdose)until the plunger member 750 has moved distally until the proximal mostrib/tooth 752 has move distally past and is no longer engaged with theleaves 762 of the ratchet rube 760. As shown in FIGS. 17 and 23A-24C,after the multiple site injection system 700 has delivered its last doseinjection, the needle 792 in the needle assembly 790 may be retractedproximally completely through the stopper member 720 and at leastpartially into the plunger member 750 so that the sharp end of theneedle 792 is no longer exposed to minimize unintended needle punctures.Such needle retraction systems are shown in co-owned U.S. patentapplication Ser. Nos. 14/696,342, 14/543,787, 14/321,706, 62/416,102,62/431,382, 62/480,276, 62/508,508, 62/542,230, 15/801,239, 15/801,259,15/801,281, 15/801,304, the contents of which were previously fullyincorporated herein by reference as though set forth in full.

FIG. 27 depicts the assembly of the multiple site injection system 700according to some embodiments. The syringe body 710 is coupled to aneedle assembly (not shown; see 790 in FIG. 26 ) and capped with aneedle shield 795 at a distal end thereof. The syringe body 710 ispre-filled with an injectable fluid (e.g., medicine) and pre-loaded witha stopper member 720. The finger flange 740 can then be coupled with(e.g., snapped onto) the syringe flange of the syringe body 710. Next,the plunger member 750 is inserted through a proximal opening in theratchet tube 760 and coupled with (e.g., screwed into) the stoppermember 720. Optionally, the proximal opening in the ratchet tube 760 canbe sealed, resulting in an assembled multiple site injection system 700.

FIG. 28 depicts a needle assembly 790 for use with the multiple siteinjection system 700 according to some embodiments. The needle assembly790 includes a needle latch 792, such as the ones described in co-ownedU.S. patent application Ser. Nos. 14/696,342, 14/543,787, 14/321,706,62/416,102, 62/431,382, 62/480,276, 62/508,508, 62/542,230, 15/801,239,15/801,259, 15/801,281, 15/801,304, the contents of which werepreviously fully incorporated herein by reference as though set forth infull. The needle latch assembly 790 also includes a retaining ring 794,such as the ones described in co-owned U.S. patent application Ser. No.62/827,767, the contents of which are fully incorporated herein byreference as though set forth in full.

FIGS. 29-36 depict a multiple site injection system 700′ according tosome embodiments. The system 700′ depicted in FIGS. 29-36 is similar tothe system 700 depicted in FIGS. 16-28 , and identical components aredescribed above. The difference between the system 700′ depicted inFIGS. 29-36 and the system 700 depicted in FIGS. 16-28 is that thesystem 700′ depicted in FIGS. 29-36 includes a staked needle assembly790′ that is not retractable. As such, the plunger member 750′ does notinclude needle retraction components. As shown in FIGS. 30 and 31 , theplunger member 750′ may be a solid body (e.g., polymer).

FIG. 32 depicts the system 700′ in an exploded view with componentsidentical to those in the system 700 depicted in FIGS. 16-28 labeledwith the same reference numerals. FIG. 33 depicts the ratchet tube 760,which is identical to the ratchet tube 760 in the system 700 depicted inFIGS. 16-28 . FIG. 34 depicts the solid plunger member 750′.

FIGS. 35 and 36 depict partial assembly of a finger flange 740/ratchettube 760 unit according to some embodiments. A return spring 748 isfirst inserted the proximal tube 742 of the finger flange 740. Then theratchet tube 760 is inserted into the proximal tube 742 of the fingerflange 740. The finger flange 740/ratchet tube 760 unit can then bemounted onto the glass/syringe flange of a syringe body and the plungermember 750′ can then be inserted through the ratchet tube 760 andcoupled to a stopper member in the syringe body. Optionally, theproximal end of the ratchet tube 760 can be closed/sealed.

FIGS. 37-42B depict some components for removing air from a syringe body(“de-bubbling” or “priming”) and moving some of the injectable fluidinto the needle by controllably advancing a plunger member 750′ of amultiple site injection system 700′ according to some embodiments. Thisprocess (“priming”) is especially useful for microdose multi-siteinjection systems. As shown in FIGS. 37-39 and 41A-41B, the system 700′includes a priming screw 761, which is coupled to the ratchet tube 760by a threaded connection, which translates rotation of the priming screw761 to distal movement thereof. The priming screw 761 rests against aproximal end of the plunger member 750′ such that distal movement of thepriming screw 761 moves the plunger member 750′ distally. The sealingpriming screw 761 defines a rectangular drive recess 763 (FIGS.41A-41B). The thumb pad 744 includes a rectangular drive boss 745 (FIGS.42A-42B), which is configured to fit in and interfere with therectangular drive recess 763 to rotate the sealing member 761 to advancethe priming screw 761 distally to drive the plunger member 750′ andcoupled stopper member distally to expel air and fluid from the needleof the system 700′. As shown in FIGS. 37, 38, and 40 , the ratchet tube760 includes a plurality (e.g. four) of latches 798 configured to couplethe thumb pad 744 to the ratchet tube 760.

FIGS. 43-47C depict some components for limiting proximal movement of aplunger member 750″ of a multiple site injection system 700″ accordingto some embodiments. As shown in FIGS. 43-46 , the finger flange 740″ ofthe system 700″ defines a chamber 747 configured to hold ananti-retraction mechanism 749. As shown in FIGS. 47A-47C, theanti-retraction mechanism 749 includes a pair of brake tabs 796configured to allow the plunger tube 750″ to move distally relative tothe anti-retraction mechanism 749, while limiting proximal movementrelative to the anti-retraction mechanism 749. Other aspects of theanti-retraction mechanism 749 are described in co-owned U.S. patentapplication Ser. No. 62/864,509, the contents of which are fullyincorporated herein by reference as though set forth in full.

FIGS. 48-54 depict a multiple site injection system 700′″ according tosome embodiments. The system 700′″ depicted in FIGS. 48-54 is similar tothe system 700 depicted in FIGS. 16-28 , and identical components aredescribed above. The difference between the system 700′″ depicted inFIGS. 48-54 and the system 700 depicted in FIGS. 16-28 is that thesystem 700′″ depicted in FIGS. 48-54 includes a plunger member 750′″without any teeth (compare to plunger member 750 the system 700 depictedin FIGS. 16-28 ). Instead of using teeth to ratchet the plunger member750′″ forward, the ratchet tube 760′″ includes a pair of the elasticallydeformable leaves 762′″ that are made of metal and configured to deformthe softer surface of the plunger member 750′″, which may be made of apolymer.

FIGS. 52A-52C depict one injection in a multiple site injection methodusing the system 700′″. When the ratchet tube 760′″ is pushed distally,the elastically deformable leaves 762′″ dig into the surface of theplunger member 750′″ and move the plunger member 750′″ distally. At theend of an injection, a return spring pushes the ratchet tube 760′″proximally while the plunger member 750′″ is held in place by frictionor by an anti-retraction mechanism as described above. Because theplunger member 750′″ has no teeth, the multiple site injection system700′″ can be used to deliver less than a full dose without disruptingthe dosage of the following injection by advancing the ratchet tube760′″ less than a full stroke before releasing the ratchet tube 760′″.

FIGS. 55-67 depict a multiple site injection system 500′ according tosome embodiments. The system 500′ depicted in FIGS. 55-67 is similar tothe system 500 depicted in FIGS. 6-15C, and identical components aredescribed above. The difference between the system 500′ depicted inFIGS. 55-67 and the system 500 depicted in FIGS. 6-15C is that thesystem 500′ depicted in FIGS. 55-67 includes a needle retractionmechanism similar to the ones depicted and described in co-owned U.S.patent application Ser. Nos. 14/696,342, 14/543,787, 14/321,706,62/416,102, 62/431,382, 62/480,276, 62/508,508, 62/542,230, 15/801,239,15/801,259, 15/801,281, 15/801,304, the contents of which werepreviously fully incorporated herein by reference as though set forth infull.

In order to facilitate needle retraction, the needle assembly 590′includes a removably coupled needle 592′, and the plunger member 550′includes needle retraction components similar to those in the patentapplication as described above. As shown in FIGS. 60 and 61 , the fingerflange 540 also includes an anti-retraction mechanism 541 is configuredto allow the plunger tube 550′ to move distally relative to theanti-retraction mechanism 541, while limiting proximal movement relativeto the anti-retraction mechanism 541. The anti-retraction mechanism 541includes a pair of brake tabs 543 as shown in FIG. 61 . Other aspects ofthe anti-retraction mechanism 749 are described in co-owned U.S. patentapplication Ser. No. 62/864,509, the contents of which were previouslyfully incorporated herein by reference as though set forth in full.

FIGS. 64-66 depict one injection cycle in a multiple site injectionmethod using the system 500′. When the ratchet tube 560 is moveddistally from FIG. 64 to FIG. 65 , the plunger member 550′ is moveddistally to eject a single dose from and teary or of the syringe body510. When the user removes pressure from the thumb pad, a spring in thefinger flange restores the ratchet tube 560 proximally to ready thesystem 500′ for the next injection/dose.

FIG. 57 depicts when the plunger member 550′ and the stopper member 520have advanced almost to a distal end of the syringe body 510 leavingonly a single dose in the interior of the syringe body 510. After thelast dose in the interior of the syringe body 510 is delivered, as shownin FIGS. 58 and 67 the retraction mechanism pulls the needle 592′ insideof the plunger member 550′ to minimize the risk of an accidental needlestick.

FIGS. 59A and 59B depict a finger flange assembly 540 prior to beingsnapped onto a syringe body. This finger flange assembly 540 isinstalled onto the syringe body in a similar fashion to the fingerflange described in FIG. 12-13 . The finger flange assembly 540 includesa plunger tube 560, which has an integral thumbpad 564 that has an openproximal end 563 for insertion of the plunger member for coupling to thestopper. The proximal end of the integral thumbpad 564 may be sealedwith a plug after insertion of the plunger member.

FIG. 63 depicts the plunger member 550′ and its components in anexploded view. In particular, a plunger cap 556 is disposed at theproximal end of the plunger member 550′. The plunger cap 556 includes adrive recess 557 configured to facilitate rotation of the plunger member550′ to threaded coupling of the plunger member 550′ to a stoppermember. The plunger cap 556 also includes a pair of latches 558configured interfere with corresponding openings in the plunger member550′ to secure the plunger cap 556 thereto. Securing the plunger cap 556to the plunger member 550′ contains the needle retraction components(e.g., needle, spring, spring latch, and needle receiving member) insideof the plunger member 550′ after needle retraction. The needleretraction components in the plunger member 550′ are similar to the onesdepicted and described in co-owned U.S. patent application Ser. Nos.14/696,342, 14/543,787, 14/321,706, 62/416,102, 62/431,382, 62/480,276,62/508,508, 62/542,230, 15/801,239, 15/801,259, 15/801,281, 15/801,304,the contents of which were previously fully incorporated herein byreference as though set forth in full.

FIGS. 68-74 depict a multiple site injection system 600 according tosome embodiments. As shown in FIGS. 68 and 69 , the system 600 includesa syringe body 610, a needle assembly 690, a needle cover 630, a stoppermember 620, a plunger member 650, and a finger flange 640. Many of thesesystem components (e.g., the syringe body 610, the stopper member 620,and the needle cover 630) may be off-the-shelf components to utilize theexisting and relatively well-controlled supply chain, and thecorresponding assembly machinery and personnel. The plunger member 650includes a thumb pad 654, coupled to a proximal end thereof tofacilitate user application of a distally directed force to the plungermember 650 and the stopper member 620 coupled thereto. As explainedbelow, the system 600 also includes an injectable fluid (e.g.,medications) disposed in a chamber in the plunger member 650.

FIGS. 70 and 71 depict the multiple site injection system 600 with andwithout the needle cover 630 attached. With the needle cover 630removed, as shown in FIG. 71 , the system 600 is ready for use. As shownin FIGS. 70 and 71 , the plunger member 650 also includes a proximalchamber 652 in which can be stored the injectable fluid. The proximalchamber 652 is open at a distal end 656 of the plunger member 650.

As shown in FIG. 72 , the distal end 656 of the plunger member 650defines a distally directed cone with an opening bid approximately thecenter thereof. The stopper member 620 includes an internal cavity 622in which the distal end 656 of the plunger member 650 is movablydisposed. The stopper member 620 also includes a proximally directedprotrusion 624 and an opening 628. Together, the distal end 656 of theplunger member 650, and the internal cavity 622 and the proximallydirected protrusion 624 of the stopper member 620 form a proximalone-way valve 626. The proximal one-way valve 626 is fluidly coupledbetween the proximal chamber 652 in the plunger member 650 and a distalchamber 612 defined by the stopper member 620 and a distal end of thesyringe body 610. In the configuration depicted in FIG. 72 , theproximal one-way valve 626 is open because the distal end 656 of theplunger member 650 is pulled proximally away from the proximallydirected protrusion 624 while the stopper member 620 is pulled distallyby glide friction between the stopper member 620 and the syringe body610 and vacuum in the distal chamber 612, thereby forming a flow pathbetween the opening in the distal end 656 of the plunger member 650 andthe opening 628 in the stopper member 620. The proximal one-way valve626 can be placed in this close configuration by applying a proximallydirected force to the plunger member 650 to pull the distal end 656 ofthe plunger member 650 away from the proximally directed protrusion 624of the stopper member 620 as explained below.

As also shown in FIG. 72 , the proximal end of the needle assembly 690includes a distal one-way valve 694. The distal one-way valve 694includes a spherical member 696 inside of a valve body 697, and a valvespring 698, which biases the spherical member 696 proximally to close aproximal opening in the valve body 697. In FIG. 72 , the distal one-wayvalve 694 is in the close configuration. With continued application ofdistally directed force to the plunger member 650 and the stopper member620 as shown in FIGS. 73 and 74 , any incompressible fluid in the distalchamber 612 will transmit the force to the spherical member 696 andovercome the force of the valve spring 698 to move the spherical member696 distally and opened the distal one-way valve 694. Opening the distalone-way valve 694 fluidly couples the distal chamber 612 and the needle692 for injection. The specific valves in this embodiment are exemplary.Other types of one-way valves are within the scope of the disclosure.

As shown in FIGS. 71 and 73 , the finger flange 640 includes a returnspring 642, which biases the plunger member 650 in a proximal position(see e.g., FIG. 71 ). When a user applies a distally directed force tothe thumb pad 654 to perform an injection, the distally directed forceovercomes the proximally directed force exerted by the return spring 642on the thumb pad 654 and advances the plunger member 650 a predetermineddistance to a distal position (see e.g. FIG. 73). Moving the plungermember 650 at the stopper member 620 from the proximal position to thedistal position ejects a known volume (e.g., 0.1 ml, microdose) from thedistal chamber 612 through the needle 692. A spectrum of volumes (e.g.,up to 0.1 ml) may also be ejected from the distal chamber 612 by movingthe plunger member 650 only a portion of the distance to the distalposition. When the plunger member 650 is advanced to perform aninjection, the proximal one-way valve 626 is closed to preventretrograde travel of fluid from the distal chamber 612 to the proximalchamber 652. In the configuration depicted in FIG. 74 , the proximalone-way valve 626 is closed because the cone at the distal end 656 ofthe plunger member 650 is pressed into the proximally directedprotrusion 624, thereby closing the opening in the distal end 656 of theplunger member 650. The proximal one-way valve 626 can be placed in thisclose configuration by applying a distally directed force to the plungermember 650 to push the distal end 656 of the plunger member 650 into theproximally directed protrusion 624 of the stopper member 620. Thestopper member 620 and the proximally directed protrusion 624 held inplace by friction between the stopper member 620 and the syringe body610 and positive pressure in the distal chamber 612. At the same time,the distal one-way valve 694 is opened by the increased pressure in thedistal chamber 612 to allow injection of fluid from the distal chamber612 through the needle 692.

When the user releases the thumb pad 654, the return spring 642 movesthe plunger member 650 proximally to return to its proximal position(see e.g., FIG. 71 ). When the plunger member 650 returns to itsproximal position (see e.g., FIG. 72 ), the distal one-way valve 694 isin its closed configuration because of the vacuum generated in thedistal chamber 612 and biasing by the valve spring 698. At the sametime, the proximal one-way valve 626 is in its open because the distalend 656 of the plunger member 650 moves proximally and the internalcavity 622 of the stopper member 620 to open the proximally directedprotrusion 624. This allows the injectable fluid in the proximal chamber652 in the plunger member 650 to be drawn into the distal chamber 612 bythe vacuum therein generated by the proximal movement of the stoppermember 620. Movement of injectable fluid from the proximal chamber 652to the distal chamber 612 readies the multiple site injection system 600for another injection. The injection process shown in FIGS. 71-74 can berepeated to give a series of injections having a fixed volume (e.g., 0.1ml, microdose).

Accordingly, a user may perform a series of injections by alternatelydepressing and releasing the thumb pad 654. With the embodiment depictedin FIGS. 68-74 , the user may optionally depress the plunger member 650less than its complete travel distance (e.g., to deliver a half orquarter dose). Regardless of the distance that the plunger member 650 isdepressed, the return stroke will draw a sufficient amount of injectablefluid from the proximal chamber 652 to the distal chamber 612 to preparefor the next injection.

While various embodiments have been described with specific connectors(e.g., slip and Luer), these embodiments can be used with any knowninjection system connectors. While various embodiments have beendescribed with staked needles and needle connectors, these embodimentscan be used with any known permanently coupled needle or needleconnector system.

Various exemplary embodiments of the invention are described herein.Reference is made to these examples in a non-limiting sense. They areprovided to illustrate more broadly applicable aspects of the invention.Various changes may be made to the invention described and equivalentsmay be substituted without departing from the true spirit and scope ofthe invention. In addition, many modifications may be made to adapt aparticular situation, material, composition of matter, process, processact(s) or step(s) to the objective(s), spirit or scope of the presentinvention. Further, as will be appreciated by those with skill in theart that each of the individual variations described and illustratedherein has discrete components and features which may be readilyseparated from or combined with the features of any of the other severalembodiments without departing from the scope or spirit of the presentinventions. All such modifications are intended to be within the scopeof claims associated with this disclosure.

Any of the devices described for carrying out the subject diagnostic orinterventional procedures may be provided in packaged combination foruse in executing such interventions. These supply “kits” may furtherinclude instructions for use and be packaged in sterile trays orcontainers as commonly employed for such purposes.

The invention includes methods that may be performed using the subjectdevices. The methods may comprise the act of providing such a suitabledevice. Such provision may be performed by the end user. In other words,the “providing” act merely requires the end user obtain, access,approach, position, set-up, activate, power-up or otherwise act toprovide the requisite device in the subject method. Methods recitedherein may be carried out in any order of the recited events which islogically possible, as well as in the recited order of events.

Exemplary aspects of the invention, together with details regardingmaterial selection and manufacture have been set forth above. As forother details of the present invention, these may be appreciated inconnection with the above-referenced patents and publications as well asgenerally known or appreciated by those with skill in the art. Forexample, one with skill in the art will appreciate that one or morelubricious coatings (e.g., hydrophilic polymers such aspolyvinylpyrrolidone-based compositions, fluoropolymers such astetrafluoroethylene, PTFE, hydrophilic gel or silicones) may be used inconnection with various portions of the devices, such as relativelylarge interfacial surfaces of movably coupled parts, if desired, forexample, to facilitate low friction manipulation or advancement of suchobjects relative to other portions of the instrumentation or nearbytissue structures. The same may hold true with respect to method-basedaspects of the invention in terms of additional acts as commonly orlogically employed.

In addition, though the invention has been described in reference toseveral examples optionally incorporating various features, theinvention is not to be limited to that which is described or indicatedas contemplated with respect to each variation of the invention. Variouschanges may be made to the invention described and equivalents (whetherrecited herein or not included for the sake of some brevity) may besubstituted without departing from the true spirit and scope of theinvention. In addition, where a range of values is provided, it isunderstood that every intervening value, between the upper and lowerlimit of that range and any other stated or intervening value in thatstated range, is encompassed within the invention.

Also, it is contemplated that any optional feature of the inventivevariations described may be set forth and claimed independently, or incombination with any one or more of the features described herein.Reference to a singular item, includes the possibility that there areplural of the same items present. More specifically, as used herein andin claims associated hereto, the singular forms “a,” “an,” “said,” and“the” include plural referents unless the specifically stated otherwise.In other words, use of the articles allow for “at least one” of thesubject item in the description above as well as claims associated withthis disclosure. It is further noted that such claims may be drafted toexclude any optional element. As such, this statement is intended toserve as antecedent basis for use of such exclusive terminology as“solely,” “only” and the like in connection with the recitation of claimelements, or use of a “negative” limitation.

Without the use of such exclusive terminology, the term “comprising” inclaims associated with this disclosure shall allow for the inclusion ofany additional element—irrespective of whether a given number ofelements are enumerated in such claims, or the addition of a featurecould be regarded as transforming the nature of an element set forth insuch claims. Except as specifically defined herein, all technical andscientific terms used herein are to be given as broad a commonlyunderstood meaning as possible while maintaining claim validity.

The breadth of the present invention is not to be limited to theexamples provided and/or the subject specification, but rather only bythe scope of claim language associated with this disclosure.

What is claimed is:
 1. A method for assembling a system for injecting, the method comprising: providing a system, the system comprising: a syringe body having proximal and distal ends, a syringe interior, and a syringe flange at the proximal end thereof; an injectable fluid disposed in the syringe interior; a finger flange coupled to the syringe flange; a stopper member disposed in the syringe interior and retaining the injectable fluid in the syringe interior; a plunger ratchet member affixed to the stopper member; and a plunger tube disposed coaxially around at least a portion of the plunger ratchet member and operatively coupled thereto; mounting the finger flange to the syringe, wherein the finger flange comprises the plunger tube having a proximal opening therein, a proximally extending tube disposed coaxially, and a return spring configured to bias the plunger tube from a distal position to a proximal position; inserting the plunger tube into the proximally extending tube thereby compressing the return spring; inserting the plunger ratchet member through the proximal opening into the plunger tube, such that the plunger ratchet member is rotatable relative to the plunger tube; and affixing the plunger ratchet member to the stopper member in the syringe interior.
 2. The method of claim 1, further comprising capping the proximal opening in the plunger tube with a thumb pad.
 3. The method of claim 1, wherein the plunger ratchet member comprises a plurality of teeth disposed on an outside surface thereof, wherein a distal end of the plunger tube comprises a reduced diameter portion configured to interfere with each tooth of the plurality to prevent distal movement of the plunger tube relative to the plunger ratchet member, the method further comprising inserting the plunger ratchet member through the proximal opening into the plunger tube until a distal most tooth of the plurality of teeth moves distally past the reduced diameter portion to thereby limit proximal movement of the plunger ratchet member relative to the plunger tube and finger flange.
 4. A method for assembling a system for injecting, the method comprising: providing a system, the system comprising: a syringe body having proximal and distal ends, a syringe interior, and a syringe flange at the proximal end thereof; an injectable fluid disposed in the syringe interior; a finger flange coupled to the syringe flange; a stopper member disposed in the syringe interior and retaining the injectable fluid in the syringe interior; a plunger ratchet member affixed to the stopper member; and a plunger tube disposed coaxially around at least a portion of the plunger ratchet member and operatively coupled thereto; mounting the finger flange to the syringe, wherein the finger flange comprises the plunger tube having a proximal opening therein, a lever, and a link operatively coupled to the lever; and inserting the plunger tube into the finger flange thereby operatively coupling the plunger tube to the lever via the link; and inserting the plunger ratchet member through the proximal opening into the plunger tube, such that the plunger ratchet member is rotatable relative to the plunger tube; and affixing the plunger ratchet member to the stopper member in the syringe interior. 